Among Medicare beneficiaries undergoing laparoscopic adjustable gastric band (LAGB) surgery, re-operation was common, costly, and varied widely across hospital referral regions, according to a study by researchers from University of Michigan, Ann Arbor.

Following the approval of the laparoscopic gastric band to treat morbid obesity by the FDA in 2001, as many as 96,000 devices have been placed annually. When the gastric band malfunctions (e.g., the band erodes into the stomach or slips down and causes obstruction) or the patient has not achieved the expected weight loss, a re-operation is indicated to replace or remove the band. The reported rates of re-operation range from 4% to 60% in short-term studies, however, there appears to be limited population-level data about the safety and costs of the device despite the continued use of it to treat morbid obesity.

"These findings suggest that payers should reconsider their coverage of the gastric band device."

Therefore, Dr Andrew M Ibrahim, from the University of Michigan, and colleagues sought to describe the rate of device-related reoperations occurring after laparoscopic gastric band surgery, as well as the associated payments in a longitudinal national cohort.

The paper, 'Reoperation and Medicare Expenditures After Laparoscopic Gastric Band Surgery', published in JAMA Surgery, included 25,042 Medicare beneficiaries who underwent gastric band placement between 2006 and 2013 and identified patients who underwent reoperations, which included device removal, device replacement, or revision to a different bariatric procedure (eg, a gastric bypass or sleeve gastrectomy).

The rates of re-operation were risk adjusted using a multivariable logistic regression model that included patient age, sex, race/ethnicity, Elixhauser comorbidities, and the year that the operation was performed.

Of the 25, 042 patients who underwent gastric band placement, 20,687 (82.61%) were white, 18,143 (72.45%) were women, and the mean age was 57.56 years. Patients (mean age, 57.5; 76.2% women) requiring re-operation had lower rates of hypertension (64.9% vs 73.4%; p<0.001) and diabetes (40.4% vs 44.6%; p<0.001) and were more likely to have their index operation at a for-profit hospital (34.6% vs 22.0%; p<0.001).

The researchers found that of the patients in the study, 4,636 (18.5 percent) underwent 17,539 re-operations (an average of 3.8 procedures/patient), with an average follow-up of 4.5-years. There was a wide geographic variation (nearly three-fold) in the rates of re-operation across hospital referral regions.

During the study period, Medicare paid US$470 million for laparoscopic gastric band associated procedures, of which US$224 million (48 percent) of the payments were for re-operations. From 2006 to 2013, the proportion of payments from Medicare for reoperations increased from 16.4% to 77.3% of their annual spending on the gastric band device.

Although a substantial number of gastric bands are still being placed, as of 2013, more than 77 percent of payments related to the device were for re-operations, reflecting either complications related to the gastric band placement or weight loss failure.

The authors acknowledge that there are several limitations of the study, including that using administrative claims data may not have captured all of the patient characteristics that could confound the results, although that effect is likely minimal, as bariatric patients often have similar underlying comorbidities that make them eligible for the procedure.

"Taken together, these findings indicate that the gastric band is associated with high re-operation rates and considerable costs to payers, which raises concerns about its safety, effectiveness, and value," the authors write. "These findings suggest that payers should reconsider their coverage of the gastric band device."

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